(207 days)
The Low level Laser model Strawberry and Strawberry and Cream can be used for the non-invasive temporary reduction in waist circumference by the disruption of adipocyte cells within the fat layer for the release of fat and lipids from these cells for non-invasive aesthetic use.
The Laser Lipo Ltd Strawberry low level laser system and Strawberry & Cream low level laser system consists of a control unit, various connection leads up to 10 paddles, 2 probes, various "Velcro" attachment straps and other accessories. A paddle is a device containing six cold red laser emitting diodes which is designed to be placed on the skin. The system can operate using 4, 6, 8 or 10 paddles that are connected to the control unit. A probe is a device containing one cold red laser emitting diode which is designed to be placed on the skin to treat specific smaller areas of fat, where a usual flat paddle won't ergonomically fit. The control unit is an electrically powered unit (100-240v, 50-60Hz auto-ranging). enabled by a main switch and key switch. Once enabled it is controlled using a button (Strawberry) or touchscreen (Strawberry and Cream) interface. The output of the diode (six per paddle) is limited to 40mW +/- 15% by a power limiting PCB from the central processing unit.
Acceptance Criteria and Device Performance Study for Laser Lipo Ltd Strawberry Low Level Laser System
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Technical Performance | ||
| Laser Diode Power Output (Paddle) | 40 mW +/- 15% (34 mW - 46 mW) | Mean: 39.35 mW (Capability, Cp: 2.47) |
| Laser Diode Power Output (Probe) | 40 mW +/- 15% (34 mW - 46 mW) | Mean: 39.02 mW (Capability, Cp: 3.49) |
| EU Portable Appliance Testing | 100% Pass | 100% Pass |
| Visual Inspection | 100% Pass (external components, cables, outer casings, general condition of all associated parts) | 100% Pass |
| Assembly Tests | 100% Pass | 100% Pass |
| Functionality Tests | 100% Pass | 100% Pass |
| Clinical Performance (Efficacy) | ||
| Temporary Reduction in Abdomen Circumference | 95% of actively treated subjects achieve a temporary reduction of 1.6 inches (4 cm) or more around the abdomen (at the height of the iliac crest). | 95% of actively treated subjects met the criteria. Average recorded loss: 3.68 inches (9.35 cm). Greatest loss: 5.6 inches (14.22 cm). One out of 22 treated subjects failed (1.2 inches reduction). |
| Placebo Response (Abdomen Circumference) | Placebo subjects should not achieve a reduction greater than 1.3 inches (3.3 cm). | Not one of the placebo subjects achieved more than 1.3 inches (3.3 cm) reduction. |
| Adverse Effects | No adverse events expected. | No adverse effects were experienced by any of the trial subjects. |
2. Sample Size Used for the Test Set and Data Provenance
- Clinical Study Test Set: 35 subjects total. 22 subjects received active laser treatments, and 13 subjects received placebo treatments.
- Technical Performance Test Sets:
- Laser diode power output (paddle): 1140 samples
- Laser diode power output (probe): 40 samples
- EU portable appliance testing: 20 units
- Visual Inspection: 20 units
- Assembly Tests: 20 units
- Functionality Tests: 20 units
- Data Provenance: The document does not explicitly state the country of origin for the clinical study data or whether it was retrospective or prospective. However, based on the submission to the CDRH (an arm of the FDA in the USA) by a UK-based company, it's likely the clinical study was conducted with a view towards US regulatory clearance. The clinical study is described as a "full double blind clinical study," which suggests it was prospectively designed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish ground truth for the clinical study beyond the measurement of waist circumference. For the technical performance tests, it appears standard engineering and quality control measurements were performed.
4. Adjudication Method for the Test Set
The document does not describe an explicit adjudication method beyond the direct measurement of waist circumference. In a double-blind study, the "ground truth" for efficacy is the measured change in circumference.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The study was a comparison between active treatment and placebo, focusing on the device's efficacy in reducing waist circumference.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This device is a physical low-level laser system for aesthetic use, not a diagnostic algorithm or AI-driven system operating without human interaction. Therefore, the concept of a "standalone" or "algorithm-only" performance study is not applicable. The performance described relates to the physical device and its clinical effect.
7. The Type of Ground Truth Used
- Clinical Studies: The ground truth for efficacy was quantitative physiological measurement (temporary reduction in waist circumference, measured in inches/cm).
- Technical Performance: The ground truth for technical tests was based on direct measurement against specified engineering tolerances (e.g., laser power output, electrical safety, visual inspection, assembly, functionality).
8. The Sample Size for the Training Set
The document does not refer to a "training set" in the context of an AI/ML algorithm. This device is a physical medical device. The "training" for such devices would involve manufacturing process controls and calibration, not data-driven algorithm training.
9. How the Ground Truth for the Training Set Was Established
As explained in point 8, the concept of a "training set" for an algorithm and its associated ground truth is not applicable to this physical low-level laser device.
§ 878.5400 Low level laser system for aesthetic use
(a)
Identification. A Low Level Laser System for Aesthetic Use is a device using low level laser energy for the disruption of adipocyte cells within the fat layer for the release of fat and lipids from these cells for noninvasive aesthetic use.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use.” See § 878.1(e) for the availability of this guidance document.